NCT01818310

Brief Summary

The aim of the presented clinical trial is to evaluate a hypothesis, that BMAC prepared from bone marrow aspirate and injected intramuscularly into ischemic areas of the lower extremity in patients with diabetes mellitus type II., intraarterially into the defect of the limb or with an intravenous application only, has a greater potential to improve the perfusion in the ischemic limbs than standard treatment of NO-CLI. Another aim of the study is to find out differences among three different therapeutic types of BMAC application, to define their effectiveness and safety and to compare the impact of different means of application to the speed of healing of the limb defects and the improvement of perfusion parameters.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2012

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2012

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 26, 2013

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

September 30, 2021

Status Verified

September 1, 2021

Enrollment Period

6 years

First QC Date

September 27, 2012

Last Update Submit

September 29, 2021

Conditions

Critical Lower Limb IschemiaType-2 Diabetes Mellitus

Keywords

ischemiadiabetes mellitusbone marrow aspirate concentrate (BMAC)

Outcome Measures

Primary Outcomes (1)

  • Amputation-free survival

    The data for Primary outcome will be collected throughout the first 18 months of the study. The assessed parameters will include amputation-free survival in order to verify the safety and efficacy of the treatment.

    18 months

Secondary Outcomes (4)

  • Tissue perfusion parameters

    4 years

  • Clinical outcome classification

    4 years

  • Functional angiogenesis imaging outcome

    4 years

  • Quality of life outcome

    4 years

Other Outcomes (3)

  • Changes in lymphocyte subsets and levels of inflammatory and antiinflammatory cytokines in each of the groups.

    24 months

  • Metabolic response

    24 months

  • Blood glucose and pancreatic function response

    24 months

Study Arms (4)

Group A: Intramuscular

EXPERIMENTAL

Intramuscular BMAC application The study subjects in the Group A will receive a treatment of 35ml BMAC administered intramuscularly into the affected limb, in individual punctures of 1 ml. The punctures will be applied into the crural muscle around the defect, the procedure takes approx. 60 minutes.

Biological: Group A: Intramuscular

Group B: Intraarterial

EXPERIMENTAL

Intraarterial BMAC application The study subjects in the Group B will receive a treatment of 35ml BMAC administered intraarterially into the affected limb.

Biological: Group B: Intraarterial

Group C: Intravenous

EXPERIMENTAL

Group C: Intravenous The study subjects in the Group C will receive a treatment of 35ml BMAC administered intravenously into the affected limb.

Biological: Group C: Intravenous

Group D: Control-standard treatment

OTHER

Group D: Control Group Study subjects in Group D will receive a standard treatment for NO-option CLI.

Procedure: Group D: Surgical endovascular treatment with maximum medicamentous treatment

Interventions

Group A: IntramuscularBIOLOGICAL

Intramuscular BMAC application The study subjects in the Group A will receive a treatment of 35ml BMAC administered intramuscularly into the affected limb, in individual punctures of 1 ml. The punctures will be applied into the crural muscle around the defect, the procedure takes approx. 60 minutes.

Group A: Intramuscular
Group B: IntraarterialBIOLOGICAL

Intraarterial BMAC application The study subjects in the Group B will receive a treatment of 35ml BMAC administered intraarterially into the affected limb.

Group B: Intraarterial
Group C: IntravenousBIOLOGICAL

Group C: Intravenous The study subjects in the Group C will receive a treatment of 35ml BMAC administered intravenously into the affected limb.

Group C: Intravenous
Group D: Surgical endovascular treatment with maximum medicamentous treatmentPROCEDURE

Group D: Control Group Control Group - no experimental intervention, standard endovascular treatment or bypass surgery or maximum medicamentous treatment

Group D: Control-standard treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • type 2 diabetes mellitus
  • diagnosis of critical limb ischemia
  • non-healing defect on the study limb
  • ABI value \< 50 mmHg or ABI\< 0.4
  • TBI value \< 40 mmHg or TBI \< 0.4
  • TcPO2 \< 20 mmHg in supine position
  • no other suitable surgical or re-vascularization procedure
  • age \> 18 years
  • signed Informed Consent

You may not qualify if:

  • non-signing of the Informed Consent
  • anticipated life expectancy \< 6 months
  • history of bone-marrow disease
  • renal failure or dialysis dependency
  • known malignant disease
  • health risks excluding the possibility of general anaesthesia or sedation
  • life-threatening ischaemic heart disease
  • vast necrosis of the index limb
  • active infectious disease, or ATB treatment
  • treatment with immunosupressives
  • pregnancy, breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ostrava

Ostrava, 708 52, Czechia

Location

Related Publications (2)

  • Dormandy J, Heeck L, Vig S. The natural history of claudication: risk to life and limb. Semin Vasc Surg. 1999 Jun;12(2):123-37.

    PMID: 10777239BACKGROUND

  • Clair DG, Dayal R, Faries PL, Bernheim J, Nowygrod R, Lantis JC 2nd, Beavers FP, Kent KC. Tibial angioplasty as an alternative strategy in patients with limb-threatening ischemia. Ann Vasc Surg. 2005 Jan;19(1):63-8. doi: 10.1007/s10016-004-0136-0.

    PMID: 15714369BACKGROUND

MeSH Terms

Conditions

IschemiaDiabetes Mellitus

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Vaclav Prochazka, MD, PhD, MSc

    University Hospital Ostrava

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2012

First Posted

March 26, 2013

Study Start

September 1, 2012

Primary Completion

September 1, 2018

Study Completion

October 1, 2018

Last Updated

September 30, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)